Clinical Application of Mg Based Biodegradable Material for Fracture Fixation in the Adult Skeleton (NCT05245981) | Clinical Trial Compass
CompletedPhase 2/3
Clinical Application of Mg Based Biodegradable Material for Fracture Fixation in the Adult Skeleton
Austria20 participantsStarted 2018-07-09
Plain-language summary
This study is a prospective, non-randomized trial for the treatment of fractures of the medial malleolus using lean, bioabsorbable, rare-earth element (REE) free, magnesium (Mg)-based biodegradable screws in the adult skeleton.
A total of 20 patients with isolated, bimalleolar, or trimalleolar ankle fractures were recruited between July 2018 and October 2019. Fracture reduction was achieved through bioabsorbable Mg-based screws composed of pure Mg alloyed with zinc (Zn) and calcium (Ca) (0.45 wt% Zn and 0.45 wt% Ca; ZX00). Visual analogue scale (VAS) and the presence of complications (adverse events) during follow-up (12 weeks) were used to evaluate the clinical outcomes. The functional outcomes were analyzed through the range of motion (ROM) of the ankle joint and the American Orthopaedic Foot and Ankle Society (AOFAS) score. Fracture reduction and gas formation were assessed using several plane radiographs.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a dislocated fracture of the medial malleolus. Dislocation is defined as diastasis of the fracture in any direction of 2 mm or more.
* Otherwise healthy patients (women and men) in the age-group 18 to 65 years
* Subject has been informed of the nature of the study, agrees to participate and signs the approved consent forms. Included in this procedure is the standard information about the operation procedure.
* Subject is able and willing to comply with all assessments in the study
* Female subject with child-bearing potential perform a pregnancy test
Exclusion Criteria:
* pathological fractures (f.e. bone cyst)
* underlying diseases (particularly bone diseases, kidney diseases, diabetes mellitus)
* poly-traumatized patient
* multiple fractures at the same extremity
* pregnant or breastfeeding women
* inability or unwillingness to give informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety: Absence of (Serious) Adverse Events (SAE) throughout the study
Timeframe: 3 years after surgery
2
Primary Efficacy- Change of stability of the distal tibiofibular joint
Timeframe: after surgery, at 2 weeks and at 6 weeks
3
Primary Efficacy- Change of stability of the fracture of the medial malleolus
Timeframe: after surgery, at 2 weeks and at 6 weeks